FDA Inspection 1268093 — SOT LLC
The FDA completed an inspection of SOT LLC on Apr 28, 2025 in Commerce City, CO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 28, 2025
- Fiscal Year
- 2025
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- Commerce City, CO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15838 | 21 CFR 111.70(d) | Specifications - labels, packaging |
| 15861 | 21 CFR 111.75(a)(2)(ii)(A) | Component - qualify supplier |
| 15984 | 21 CFR 111.123(a)(8) | Quality control - finished batch, distribution |
| 22843 | 21 CFR 111.70(b) | Specifications - components |
| 22847 | 21 CFR 111.70(e) | Specifications - finished dietary supplement |
| 22854 | 21 CFR 111.83(b) | Reserve sample - container-closure system |
| 22868 | 21 CFR 111.140(b)(2) | Records - date and signature; review, approval, rejection |
| 22884 | 21 CFR 111.205(a) | Master manufacturing record - prepared |
| 22890 | 21 CFR 111.260 | Batch record - required information |
| 22912 | 21 CFR 111.560(a) | Product complaint - qualified person review & investigate |